Invited Speakers/Visitors

NICHD Staff

Kristy AlstonBeth AnselMel CarterMarita Hoppman

Chrisoula JenningsLisa KaeserAnne KreyJohn McGrath

Ralph NitkinLouis QuatranoMona RoweCarol Sheredos

Laurence Stanford

REPORT OF THE NICHD DIRECTOR

Dr. Duane Alexander reviewed legislation and other National Institutes of Health (NIH) news. The NICHD budget is currently at $976 million and should surpass $1 billion in the next appropriation. It ranks as the eighth largest institute at the NIH. The NIH is currently in the third year of the five-year drive to double the budget, but the organization must look ahead to times when increases may not be as generous. Unfortunately, other federal agencies, such as the National Science Foundation (NSF), Center for Disease Control and Prevention (CDC), and the Health Resources and Services Administration (HRSA), have not done as well with budget increases. The NIH awaits appointment of the Assistant Secretary for Health and a new NIH Director. NICHD is conducting a national search to replace the recently retired Dr. Sumner Yaffe as the director of the Center for Research for Mothers and Children.

Current legislation calls for the formation of a new NIH institute to support research on radiology and bioengineering. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) will begin with grants transferred from other NIH institutes, which will have particular impact on the NCMRR because of the relevance of bioengineering and imaging approaches to medical rehabilitation research. NIH support for embryonic stem cell research has been put on hold, although research involving stem cells of non-embryonic origin continues. The NICHD is leading a consortium to support a major longitudinal study of environmental influences on health and development. Researchers in the area of disability and rehabilitation may also be interested in following this cohort of children. Lastly, the loan repayment program for clinically trained individuals, discussed at the previous NCMRR advisory meeting, is still being worked out.

REPORT OF THE NCMRR DIRECTOR

Dr. Michael Weinrich indicated that last year's NCMRR budget was $37.5 million and it should go even higher this year. Recent NCMRR workshops include stroke and hip fracture, home mechanical ventilation, and a trans-NIH rehabilitation meeting focusing on mobility. Recent research initiatives from the NCMRR focus on innovative rehabilitation approaches, planning grants to promote clinical trails in pediatric rehabilitation, clinical trial networks in traumatic brain injury, and pharmacological approaches for treatment of brain injury. The Center is currently recruiting for a pediatric critical care specialist to further develop pediatric rehabilitation research programs.

UPDATE ON CDC ACTIVITIES

Don Lollar provided an update on CDC activities in the area of medical rehabilitation. Healthy People 2010 makes special reference to eliminating health disparities among people with disabilities in Chapter 6, Disabilities and Secondary Conditions. The World Health Assembly (WHA) updated the International Classification of Function, Disabilities and Health. The CDC participated in these efforts and hopes that the US will adopt the WHA standard, which is comparable to the earlier International Classification of Disabilities (ICD). Jose Cordero, MD, MPH, has been named acting director of the newly created National Center on Birth Defects and Developmental Disabilities (NCBDDD) at CDC. The Disabilities and Health Group is part of the new center, and Dr. Cordero has show enthusiasm for balancing prevention activities across birth defects, developmental disabilities and secondary conditions. The new NCBDDD looks forward to working with NCMRR.

CONCEPT CLEARANCE: WORKSHOPS AND RESEARCH INITIATIVES

Because of its expertise, the Board is called on to provide an additional level of review for specific NCMRR initiatives. Dr. Laurence Stanford, Director, Division of Scientific Review, NICHD, led this part of the discussion. Background material on each of the following five proposals was distributed prior to the meeting.

The Board endorsed the development of a Request for Applications (RFA) on quantitative modeling to guide therapeutic interventions in motor disorders. They discussed the proposal in terms of mechanical versus neuronal models of movement and the potential for hypothesis testing and improved outcomes development. This RFA could provide opportunities to link gait modeling with imaging in order to improve the evaluation of potential therapeutic interventions.

The Board gave positive feedback on an initiative to study chronic changes in muscle associated with disuse. Perhaps this could be expanded to include the changes resulting from disorders such as AIDS or cancer.

The Board felt that the initiative on dynamic health assessments for medical rehabilitation outcome measures was a high priority, recommending that it go beyond current measures of activities of daily living and physical impairment to include psychosocial outcomes and participation. The use of dynamic assessment approaches was also seen as an important advance. The NICHD should consider an interagency collaboration with the National Institute on Disability and Rehabilitation Research (NIDRR) and CDC.

The Board was very excited about the proposal on behavioral issues in persons with disabilities. However, it warned that the term "behavior management" has specific connotations that may not be appropriate in this context; a better term would be "neurobehavioral issues". This initiative should include speech and language pathology, cognitive issues, executive function, emotion, and environmental influences.

The Board endorsed the development of a cooperative multicenter pediatric critical care network, and noted that it is important to link acute care to long-term outcome. The Board stressed the inclusion of functional outcomes rather than those that are strictly biomedical, which could include behavioral issues and schooling.

NATIONAL SCIENTIST DEVELOPMENT PROGRAM

Dr. John Whyte provided an update on the NICHD-funded national scientist development program in medical rehabilitation research, which is supported through the K12 mechanism. He provided background on the motivation for a special training program in this area based on the need for increased evidence-based research and the unique paradigms of medical rehabilitation. Recent graduates in physical medicine and rehabilitation have high clinical demands and cannot succeed in academic jobs without extensive research training. The K12 mechanism, which has been used successfully in other medical specialties, supports centralized recruitment and mentorship oversight. Under this program, trainees work in a mentored basic science environment for two to three years, and continue to receive support during the first years of their faculty appointment. The program has explicit expectations and career milestones, and provides trainees with a roster of prospective mentors and career counseling and networking opportunities.

VOTE FOR NEW CHAIR-ELECT

In accordance with current Board procedures, elections for the new chair-elect were held. Dr. Thomas Strax was elected, and he will succeed Chukuka S. Enwemeka, who advances to the position of Chair at the December 2001 meeting.

NATIONAL CENTER FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE

Dr. Christine Goertz provided some background on the formation of the NCCAM and its current research agenda. The Center defines complementary and alternative as those procedures that go beyond conventional medical practice; typically these are procedures that are not supported by medical insurers. Such procedures include mind-body interactions, manipulative and body-based methods, and energy theory. The NCCAM approaches tend to have the following characteristics: enhance the body's own healing, involve individualized therapies, and use a whole-body approach. In the evaluation of prospective research proposals, the NCCAM looks for credible preliminary data and considers such factors as extent of use by the US public, health significance, and the availability of appropriate patient populations and appropriate expertise. The Center also supports outreach to consumers, practioners and investigators.

BREAKOUT GROUPS TO UPDATE NCMRR RESEARCH PRIORITIES

Dr. Weinrich presented the breakout sessions as a means to continue discussions from previous Board meetings on the potential need to update the NCMRR research plan. Rather than drafting a new document, the sessions are seen as an opportunity to discuss the capabilities and boundaries of medical rehabilitation research, as well as potential strategies for evaluating and updating NCMRR goals. NCMRR Board members, staff, and guests reconvened into three working groups. At the end of the first day and at the beginning of the second day, each group reported back to Board as a whole.

The last decade has seen significant changes in society, which impact on medical rehabilitation, including Medicare reform, changing family demographics, the rise in consumerism, increased independence of individuals with disabilities, and the rise of the Internet. Nonetheless, the NCMRR model for medical rehabilitation (i.e., pathophysiology, impairment, functional limitation, disability, and societal limitation) still works. There is a need to apply rehabilitation to a broader population, and to focus on "not just adding years to life, but adding life to years". The disability community is generally receptive to current biomedical approaches and is promoting the concept of "wellness". The current focus is on increased productivity and independence, as well as the maintenance of health through transient periods of crisis. Health consumers are more proactive about health, fitness and nutrition. They have become empowered through the use of the Internet, E-health, telecommunication, and other advances in informatics.Changes in health administration have altered rehabilitation practices, leading to shorter hospital stays and changes in the rehabilitation settings. Increased regulation directly affects provider behavior, performance and, ultimately, rehabilitative outcomes.

Research methodology has also evolved to incorporate individual difference models, better assess changes over time, and evaluate more complex interventions. Participation has become a more significant outcome variable, with research into its conceptualization and measurement and adaptive strategies. Rehabilitation research must also take into account the changing demographics of the American family, reduced societal support, and the disassembly of the traditional rehabilitation team.

2) Basic Research Relevant to the NCMRR

Advances in imaging have allowed for earlier diagnosis, more objective outcome measures, and increase insight into mechanisms. Gene expression techniques provide novel means of analyzing the recovery process and identifying potential therapeutic targets. Stem cells and transgenic cell lines can be used to augment tissue recovery. Genetic epidemiology could be used to optimize therapeutic interventions and better predict the course of recovery. Studies in the neuroregulation and biomechanics of motor control and the mechanisms of disuse and over-use syndromes are highly relevant to medical rehabilitation. There is increasing emphasis the physiological changes associated with the transition from the acute to the chronic phase of disability. Biobehavioral research on motivation and compliance can be used to support rehabilitative strategies. Likewise, the study of cognitive enhancement, applied behavior, and generalizability has direct relevance to the treatment of learning and memory deficits.

3) Bioengineering: Assistive Technologies and Device Development

The NCMRR should encourage the application of all areas of technology to rehabilitation engineering. More emphasis should be placed on the development of bioengineering teams to promote rehabilitation research and development, with emphasis on transdisciplinary communication. More attempts should be made to support undergraduates and masters students in pilot engineering projects. There are exciting new developments in the area of neural and limb prostheses (e.g., direct skeletal attachment and implantable devices), advanced mobility aids, robotically aided therapy, and tissue restoration. Engineers should also consider long-term impact (e.g., reducing the stress of assistive devices) and preventative strategies (e.g., reducing the chance of falls among the elderly and frail).

CONCLUDING REMARKS ON NCMRR RESEARCH PRIORITIES

Medical rehabilitation research impacts on professional training in physical medicine and rehabilitation (PM&R) department. Perhaps the Center should increase interactions with professional societies and advocates, such as the University Affiliated Programs (UAP) and the Independent Living movement. Medical rehabilitation research should consider emerging disorders such as brain cancer, breast cancer, organ transplants (causing deconditioning), AIDS, multiple chemical sensitivity, osteoporosis, diabetes, child and adult asthma, and Alzheimer disease. The border between acute care and rehabilitative medicine is becoming blurred. The Center should develop research initiatives in such areas as use and inactivity, fitness and exercise, obesity, and aging with disabilities. Groups such as Blue Crossä and Kaiserä sponsor research and databases, and perhaps the NCMRR should consider working with these stakeholders in further research initiatives. Among patients, the Center should study the factors that affect participation and strategies for reinforcing positive behaviors. Although function and participation are the goals of medical rehabilitation, health care providers are still driven by the diagnosis, so perhaps the Center should develop studies to highlight the cost savings and other benefits of enhancing function and participation.

Medicine is criticized today because the health care professional is being increasingly relegated to the role of a technician. Diagnosis is driving medical practice. Rehabilitation medicine is the one specialty that focuses on using medical knowledge to enhance how a person can live (i.e., potential) and the choices he or she can make (participation). The Center should identify rehabilitative and medical interventions that enhance a person's downstream potential to participate in life circumstances that are personally meaningful.

IMPROVING COMMUNICATION BETWEEN NCMRR AND ITS CONSTITUENCIES

There is some concern that the NCMRR is not communicating effectively with its advocacy groups and the public in general. NIDRR and CDC are also struggling with these issues. The NCMRR needs to communicate not only current research supported by the NIH, but also implications and future possibilities. How does this research affect outcomes for people with disabilities? The popular press and the disability press in particular seem to gravitate toward human-interest stories and personal anecdotes. Unfortunately, it is easier to promote pills, gizmos, and fMRIs than human therapy. One possibility is the development a multiyear "marketing" plan with specific goals, although this may not be appropriate with tighter fiscal constraints at the NIH in the years ahead. These issues will have to be discussed further at future Board meetings.

DEVELOPMENT OF THE NIH APPROPRIATION

George Gaines, NICHD's legislative liaison, described the appropriation process. The annual appropriation actually represents a 30-month process, with 18 months of development and 12 months of accountability. The developmental process starts with the formulation of the president's budget, followed by discussions in Congress, and finally the implementation phase. Thus, planning of the fiscal year 2001 budget actually began in 1999, with evaluation of ongoing commitments and projections under various potential funding scenarios. Projections from each NIH institute are then modified to fit a presidential target, further modified for House targets, and refined for Congressional Conference Committee targets. Ultimately, the Office of Management and Budget gives the NIH an official allowance and the Director of the NIH provides to Congress a formula for how funds will be divided among the NIH components. During the years 1989 through 1999, the NICHD got increases below the NIH average, but this has been rectified in more recent allocations by the acting NIH Director.

Dr. Susan McDermott, currently a fellow on the staff of Senator Jeffords, provided some additional insights into the appropriation process. The budget proposal is just a blueprint; the final allocation provides the actual dollar mounts. Both the Senate and the House have specific subcommittees for the NIH, which make recommendations back to the respective full committees, and then on to the floor of the House and the Senate. The Congressional Conference Committee works out a compromise bill. Fortunately, there is strong bipartisan support for the NIH in Congress. Dr. McDermott stressed the importance of being connected to the majority party because they set the agenda.

DISCUSSION OF ACCOMMODATION AND ACCESSIBILITY ISSUES

Carol Sheredos, a visiting fellow at the NCMRR, provided an excellent review of disabilities awareness at the NIH. Although there was a federal ruling in 1995 that the Department of Health and Human Services must provide services based on need, the issue of accommodation within the NIH was highlighted by a 1998 complaint from a deaf employee who was seeking interpretative services. That same year, President Clinton signed an Executive Order to establish a presidential task force on employment of adults with disabilities. The task force recommended the development of a plan to increase the representation of adults with disabilities in the federal workforce. Within the NIH, the Disabilities Awareness Task Force was created to represent the large range of disability interests among employees and to promote and update accommodation policies. The task force focused on facilities accessibility, reasonable accommodation, employment, communications access, administrative issues, and public relations. Although 37 percent of the American workforce has a declared disability, the percentage within the NIH is only about 5 percent. The NIH has pledged to substantially improve on this record.

NEW BUSINESS AND AGENDA FOR NEXT MEETING

Several issues were raised for discussion at future Board meetings. These included quality-of-life assessment, demonstration of new dynamic measurement approaches, cognitive rehabilitation, and tissue engineering. The Board also raised the possibility of discussing how research impacts on professional curriculum development, possibly involving discussions with the American Congress of Rehabilitative Medicine (ACRM). There was also a suggestion that the Board should invite a few of its current members who have experiences and expertise in particular areas relevant to ongoing discussions to give presentations.

ACKNOWLEDGEMENT OF RETIRING BOARD MEMBERS AND COMMENTS

NCMRR appreciates the efforts of the following Board members who have completed their terms: Dr. Dudley S. Childress, Dr. Chung Y. Hsu, and especially Dr. Margaret Stineman who served as Chair in her final year of service. The retiring members made parting comments and were presented with special certificates signed by the Director of NIH.